Nutritional Status
Conditions
Brief summary
The purpose of this study was to evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper and lower body strength.
Interventions
DIETARY_SUPPLEMENTWhey protein and creatine supplement
Each sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
DIETARY_SUPPLEMENTWhey protein only supplement
Each sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
DIETARY_SUPPLEMENTPlacebo
Each sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Recreationally active males * Age 18 to 35 years * BMI 19 to 29.9 kg/m2 * Weight training 3 to 4 times a week for at least 6 months before the trial
Exclusion criteria
* Participants with medical conditions including active heart disease, high blood pressure, renal or hepatic impairment type I or II diabetes, bipolar disease, pulmonary disease, thyroid disease, immune disorder, psychiatric disorder * Dietary or herbal supplement used in the past 60 days to increase muscle mass * Use of protein supplement in the past 7 days * Use of thermogenic supplement or beverage in the past 7 days * Use of Non-steroidal anti inflammatory drugs or corticosteroids in the past 7 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on change in upper body strength from Baseline to Week 4. | Baseline, Week 2, 4, 8 and 12 | Body strength will be evaluated using Repetition maximum (1-RM) and bench and leg press exercise testing. 1-RM in weight training is the maximum amount of weight one can lift in a single repetition for a given exercise |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare changes in upper and lower body strength from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo. | Baseline, Week 2, 4, 8 and 12 | Body strength will be evaluated using 1-RM and bench and leg press exercise testing |
| To compare changes in upper and lower body endurance from Baseline through Week 12, between combined whey protein and creatine supplement, whey protein supplement alone, and placebo. | Baseline, Week 2, 4, 8 and 12 | Body endurance will be measured using bench press and leg press exercise testing |
| To compare the changes in lean vs. fat body mass composition from Baseline to Week 12 between combined whey protein and creatine supplement, whey protein supplement alone, and placebo. | Baseline and Week 12 | Body composition \[(fat-free mass and fat mass (grams and % body fat, bone mass)\] will be calculated using Dual X-Ray Absorptiometry (DXA) |
| To evaluate the effect of combined whey protein and creatine supplement, as compared with whey protein supplement alone, on changes in upper and lower body strength from Baseline through Week 12 | Baseline, Week 2, 4, 8 and 12 | Body strength will be evaluated using 1-RM and bench and leg press exercise testing |
| To evaluate the effect of combined whey protein and creatine supplement, as compared with placebo, on changes in upper and lower body strength from Baseline through Week 12. | Baseline, Week 2, 4, 8 and 12 | Body strength will be evaluated using 1-RM and bench and leg press exercise testing |
Countries
United States
Outcome results
None listed